The ExPO Trial (Exercise Prior to Oesophagectomy)
Research type
Research Study
Full title
A pre-operative personalised exercise programme to improve physical fitness and reduce post-operative cardiopulmonary complications after oesophagectomy in patients with oesophageal adenocarcinoma – a feasibility randomised controlled trial.
IRAS ID
206608
Contact name
Andrew Hart
Contact email
Sponsor organisation
University of East Anglia
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
The number of patients with oesophageal cancer is rising dramatically in the UK. Curative cancer surgery (oesophagectomy) is offered to around 40% of affected patients. However, oesophagectomy is a major operation with a high risk of complications. Around 1 in 3 patients will have a complication after surgery, mostly due to heart or lung problems. Most complications are not due to the surgery itself, but related to the patient’s physical fitness before their operation. Studies in other surgeries, but not oesophagectomy, have shown that complications may be reduced by improving a patient’s physical fitness before their operation. The ExPO team has developed a pre-operative Personalised Exercise Programme (PEP), specifically for patients undergoing oesophagectomy. The PEP has 4 main components: three are exercise modalities (aerobic exercise, breathing exercises and muscle strengthening); the fourth is where a participant’s potential barriers to exercise are assessed and behavioural change techniques (BCTs) are suggested to improve exercise engagement in the trial. 32 patients who are due to undergo oesophagectomy at the Norfolk and Norwich Hospital will be recruited and then randomly divided into 2 arms of 16 each. One arm will receive the PEP in the standard 3-4 months prior to surgery, the other will receive standard care advice to exercise at home. The research objectives are to obtain feasibility data on whether PEP is acceptable, adhered to and safe, and whether it improves patient fitness above standard care. Follow up will be 90 days after surgery to obtain a preliminary imprecise estimate of whether PEP reduces complications. If the ExPO trial shows promise in these areas, this will inform and justify a future large multi-centre trial to definitively answer whether PEP can reduce complications after oesophagectomy. If so, PEP could potentially change and improve the pre-operative management of oesophageal cancer patients across the NHS.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
16/EM/0317
Date of REC Opinion
8 Aug 2016
REC opinion
Further Information Favourable Opinion